"Conducted by 5 Companies... 2 Sites Expected to Reach Phase 2 and 3 Clinical Trials by Year-End"

Genexine's DNA vaccine GX-19 clinical trial drug. Phase 2 clinical trial is currently underway. <br>[Image source=Yonhap News]

Genexine's DNA vaccine GX-19 clinical trial drug. Phase 2 clinical trial is currently underway.
[Image source=Yonhap News]

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[Asia Economy Reporter Lee Chun-hee] It is expected that domestically produced COVID-19 vaccines could receive government approval for use as early as this year.


On the 26th, Kwon Deok-cheol, Minister of Health and Welfare, appeared on MBC Radio's "Kim Jong-bae's Focus" and said regarding domestic COVID-19 vaccine development, "Five companies are currently progressing," and "Two of them are expected to reach clinical phases 2 and 3 by the end of the year." He anticipated the approval timing to be "as early as the end of this year or early next year."


Currently, in South Korea, five companies?SK Bioscience, Genexine, GeneOne Life Science, Cellid, and UbioLogics?have received approval for vaccine clinical trials and are conducting tests. Among them, Genexine's DNA vaccine and Cellid's adenovirus vaccine recently entered clinical phase 2 and phase 2a trials, respectively.


SK Bioscience has developed two recombinant antigen vaccine candidates, 'NBP2001' and 'GBP510,' currently undergoing clinical phase 1 and phases 1 and 2 trials, respectively. UbioLogics' recombinant antigen vaccine and GeneOne Life Science's DNA vaccine are also in phase 1 clinical trials. These companies are accelerating development with the goal of entering phase 3 trials in the second half of this year.


When asked whether these vaccines could be administered as early as the beginning of next year, Minister Kwon replied, "We are hopeful and the government is providing various supports," but added, "Since the number of patients in our country is not very high, whether phase 3 trials proceed as planned depends on how they are conducted."


He also mentioned that they are monitoring whether the schedule can proceed as originally planned by using "external indicators" comparing international organizations or multinational pharmaceutical companies' existing methods with domestically developed vaccines, and that they will "seek and provide maximum support."


On the 24th, Kwon Deok-cheol, head of the Vaccine Introduction Task Force (Minister of Health and Welfare), spoke at the joint emergency briefing of related ministries on the introduction of COVID-19 vaccines held at the Government Seoul Office in Jongno-gu, Seoul. [Image source=Yonhap News]

On the 24th, Kwon Deok-cheol, head of the Vaccine Introduction Task Force (Minister of Health and Welfare), spoke at the joint emergency briefing of related ministries on the introduction of COVID-19 vaccines held at the Government Seoul Office in Jongno-gu, Seoul. [Image source=Yonhap News]

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Minister Kwon also explained the additional contract for 20 million doses (40 million shots) of Pfizer vaccines announced by the government on the 24th. With this, the total number of vaccines secured by the government has increased to 99 million doses (192 million shots).


He said, "On the 1st, we formed an intergovernmental vaccine procurement task force and held relay meetings with various vaccine pharmaceutical companies," and that after meetings with Pfizer on the 9th and 23rd, the contract was signed on the 24th. He added, "I heard that Pfizer's production efficiency has significantly increased," and said, "We started with 'let's review it,' and I think a good result came out."


However, since the supply schedule for the additional procurement volume, including this contract, has not been disclosed in detail, controversy over vaccine supply has not been completely resolved.


Regarding this, Minister Kwon said, "We are also regretful," and explained, "Contracts include confidentiality clauses internationally, and no country discloses quarterly or daily supply plans." He added, "If a specific country reveals when and how much will arrive, other countries would also want the same information," and said, "We have agreed to 'supply stably. While the total volume is presented, the detailed schedule will be provided shortly before, about a month or weekly in advance, so it would be good to receive it then."


He also dismissed concerns about possible disruptions in vaccine supply, emphasizing, "We will continuously monitor to ensure no disruptions," and "Since Pfizer is a global company, I believe they will keep their promise to send a certain amount regularly."


Samsung Electronics Vice Chairman Lee Jae-yong is attending the retrial sentencing hearing of the state affairs manipulation case held at the Seoul Central District Court in Seocho-gu last January. [Image source=Yonhap News]

Samsung Electronics Vice Chairman Lee Jae-yong is attending the retrial sentencing hearing of the state affairs manipulation case held at the Seoul Central District Court in Seocho-gu last January. [Image source=Yonhap News]

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Regarding reports that Samsung Electronics Vice Chairman Lee Jae-yong, currently incarcerated, played various roles in the initial contract process for Pfizer vaccine procurement, Minister Kwon said, "I was not present at that time," and "It is difficult to confirm." On the broader role of Lee Jae-yong in vaccine procurement, he said, "I believe it is true that public and private sectors worked together," but added, "This negotiation with Pfizer was conducted based on the government's credibility."


Minister Kwon also indicated intentions to improve the compensation and support system for adverse reactions following vaccination, which surfaced after a case of a nurse in her 40s experiencing limb paralysis after AstraZeneca (AZ) vaccination.


He said, "If a causal relationship between vaccination and adverse reactions is established, support will be provided according to the Infectious Disease Control and Prevention Act. In cases where causality cannot be confirmed, at least medical expenses or funeral costs in cases of death should be institutionally supported," and added, "We will discuss this within the government and with the National Assembly."



When asked if they are considering amending the Infectious Disease Control and Prevention Act, he replied, "I think it is necessary," but added, "Since the main department is the Korea Disease Control and Prevention Agency, we will consult with them."


This content was produced with the assistance of AI translation services.

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